Dasatinib in Treating Patients With Advanced Lung Cancer That Is No Longer Responding to Erlotinib or Gefitinib

Lung Cancer Clinical Trial

Official title:

A Phase 2 Trial of Dasatinib in Patients With Lung Adenocarcinoma With Acquired Resistance to Erlotinib or Gefitinib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570401
• Other study ID #: Mskcc 06-143
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2007
• Last updated: December 16, 2015
• Start date: June 2006
• Est. completion date: September 2011

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with advanced lung cancer that is no longer responding to erlotinib or gefitinib.

Description:

OBJECTIVES:

Primary

• To determine the overall response rate (complete response and partial response) in patients with acquired erlotinib hydrochloride- or gefitinib-resistant advanced adenocarcinoma of the lung treated with dasatinib.

Secondary

• To determine the progression-free survival and overall survival of patients treated with this drug.

• To determine the overall response rate in patients with EGFR T790M lung adenocarcinomas treated with this drug.

• To determine the progression-free survival and overall survival of patients with EGFR T790M lung adenocarcinomas treated with this drug.

• To determine the toxicity profile of dasatinib in these patients.

OUTLINE: Beginning 1 week after completion of erlotinib hydrochloride or gefitinib therapy, patients receive oral dasatinib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Response is assessed by CT scan at 4 weeks, 8 weeks, and then every 8 weeks thereafter.

Other known NCT identifiers

• NCT00590057

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Pathologically confirmed adenocarcinoma of the lung

• Advanced disease

• Previously treated with erlotinib hydrochloride or gefitinib for 6 months (at any time) and meets 1 of the following criteria:

• Previously received treatment with erlotinib hydrochloride or gefitinib* and had a radiographic partial or complete response to treatment with erlotinib hydrochloride or gefitinib as defined by RECIST or WHO criteria

• Documented mutation in EGFR from tumor DNA NOTE: *Patients may have received other treatments subsequently including radiation or chemotherapy

• Must have developed acquired resistance to erlotinib hydrochloride or gefitinib

• Radiographic evidence of disease progression during treatment with erlotinib hydrochloride or gefitinib

• Have previously undergone a biopsy of a site of progressive disease on protocol MSKCC 04-103* NOTE: *Results of this biopsy are not required to be enrolled on this trial

• Measurable indicator lesions have not been previously irradiated

• No CNS lesion that is symptomatic and/or requiring escalating doses of corticosteroids

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• WBC = 3,000/mm³

• Hemoglobin = 9.0 g/dL

• Platelet count = 100,000/mm³

• Total bilirubin = 2.0 mg/dL

• AST and ALT = 2.5 times upper limit of normal

• Creatinine = 2 mg/dL or creatinine clearance = 55 mL/min

• QTc < 450 msec

• Able to take oral medications

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 4 weeks after study drug is stopped

• No significant medical history or unstable medical condition, including any of the following:

• History of diagnosed congenital long QT syndrome

• Ventricular arrhythmia

• Congestive heart failure

• Recent myocardial infarction

• Unstable angina

• Active infection

• Uncontrolled hypertension

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 3 weeks since prior cytotoxic chemotherapy

• At least 3 weeks since prior radiation therapy to a major bone-marrow containing area

• At least 7 days since prior quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycin, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, or lidoflazine

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• dasatinib

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Johnson ML, Riely GJ, Rizvi NA, Azzoli CG, Kris MG, Sima CS, Ginsberg MS, Pao W, Miller VA. Phase II trial of dasatinib for patients with acquired resistance to treatment with the epidermal growth factor receptor tyrosine kinase inhibitors erlotinib or ge — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the Overall Objective Response	To determine the overall response rate in patients with acquired erlotinib hydrochloride- or gefitinibresistant advanced adenocarcinoma of the lung treated with dasatinib using the RECIST criteria. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.22 Changes in only the largest diameter (uni-dimensional measurement) of the tumor lesions are used in the RECIST.	2 years	No